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Trial record 1 of 626 for:    i nursing
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Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients (I-Nursing)

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ClinicalTrials.gov Identifier: NCT03176329
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Chelly Jonathan, Hopital of Melun

Tracking Information
First Submitted Date  ICMJE May 28, 2017
First Posted Date  ICMJE June 5, 2017
Last Update Posted Date August 15, 2018
Actual Study Start Date  ICMJE September 19, 2016
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2017)
Time spent with SpO2 values > 90 and < 95% [ Time Frame: 1 day ]
Pulse oxymetry monitoring
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2017)
  • Time spent with SpO2 values < or = 90% [ Time Frame: 1 day ]
    Pulse oxymetry monitoring
  • Time spent with SpO2 values > or = 95% [ Time Frame: 1 day ]
    Pulse oxymetry monitoring
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients
Official Title  ICMJE Closed-loop Versus Conventional Ventilation Mode During Mobilization Period in Critical Care Patients : a Prospective Randomized Crossover Study
Brief Summary

Nursing is essential in critically ill patients care but with high risk of hypoxia, especially during mobilization. Full closed-loop control ventilation is well established for her safety in unselected ventilated critical care patients with different lung conditions compared to conventional ventilation.

The aim of this study is to assess the ability of a full closed-loop control ventilation (Intellivent-ASV, TM) to reduce hypoxia during mobilization period in unselected ventilated patients.

Detailed Description

Prospective randomized cross over study including all consecutive ventilated patient with predicted duration of ventilation > 48 hours, inspired oxygen fraction < 60% and without neuromuscular blocking agent.

Patient were randomized to be ventilated with full closed-loop control or conventional ventilation 30 minutes before the first nursing period after inclusion. The ventilator was switched in the other mode (conventional or full closed-loop respectively), 30 minutes before the following nursing period. Between this two consecutive nursing periods, ventilation mode is choosed by the attending physician.

The primary outcome was the oxygenation measured by pulse oxymetry during the nursing periods.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Prospective randomized crossover study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Critical Ill Patients
  • Ventilated Patients
Intervention  ICMJE
  • Other: Nursing 1 : INTELLIVENT-ASV
  • Other: Nursing 2 : INTELLIVENT-ASV
  • Other: Nursing 1 : Conventional mode
  • Other: Nursing 2 : Conventional mode
Study Arms  ICMJE
  • INTELLIVENT-ASV / Conventional mode
    Full closed-loop ventilation control (INTELLIVENT-ASV) is set 30 minutes before Nursing 1 after randomization. Ventilator is switch to conventional ventilation 30 minutes before Nursing 2
    Interventions:
    • Other: Nursing 1 : INTELLIVENT-ASV
    • Other: Nursing 2 : Conventional mode
  • Conventional mode / INTELLIVENT-ASV
    Conventional ventilation control is set 30 minutes before Nursing 1 after randomization. Ventilator is switch to full closed-loop ventilation (INTELLIVENT-ASV) 30 minutes before Nursing 2.
    Interventions:
    • Other: Nursing 2 : INTELLIVENT-ASV
    • Other: Nursing 1 : Conventional mode
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2017)
267
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2018
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Invasive mechanical ventilation for expected time >48h

Exclusion Criteria:

  • Pregnancy
  • Neuromuscular blocking agent (discontinuous or continuous) infusion
  • Inspired oxygen fraction (FiO2) setting > or = 60%
  • Mobilization contraindication (hemodynamic instability, unstable vertebral trauma, etc.)
  • Neurological breathing (patients with brain injury)
  • Pulse oxymetry monitoring unavailable
  • Expected ventilation weaning <24h after randomization.
  • Moribund patients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03176329
Other Study ID Numbers  ICMJE MelunH-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chelly Jonathan, Hopital of Melun
Study Sponsor  ICMJE Hopital of Melun
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan Chelly, MD Mixed, ICU, Centre Hospitalier de Melun
PRS Account Hopital of Melun
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP